(51 days)
Not Found
No
The device description and performance studies focus on mechanical components and mesh properties, with no mention of AI/ML terms or functionalities.
Yes
The device is described as a system for vaginal vault suspension to treat pelvic organ prolapse, indicating it is used for treatment.
No
The device is described as a "Suspension System" used to "pass a polypropylene mesh for support of the vaginal vault" to treat pelvic organ prolapse, indicating a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly states it consists of needles, connectors, and polypropylene mesh, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in vaginal vault suspension to treat pelvic organ prolapse." This is a surgical procedure performed on a patient's body.
- Device Description: The device consists of "needles and connectors used to pass a polypropylene mesh for support of the vaginal vault." These are surgical tools and implants.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to diagnose diseases or conditions.
This device is clearly a surgical device used in vivo (within the body), not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Apoqee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ prolapse.
Product codes (comma separated list FDA assigned to the subject device)
OTP
Device Description
The Apogee™ Vault Suspension System consists of needles and connectors used to pass a polypropylene mesh for support of the vaginal vault.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal vault
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The mesh used in the Apogee™ Vault Suspension System has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated substantial equivalence to the predicate devices in terms of mechanical performance and biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AMS Sparc Sling System - K011251, K013355, K020663, AMS Monarc Sling System - K023516, AMS BioArc - K030123, AMS Large Pore Polypropylene Mesh - K033636, IVS Tunneller - K010035
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.
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APR 2 2 2004
page 4/2
510(k) Summary AMS Apogee™ Vault Suspension System KO4053
510(k) Number
Date of Summary Preparation: March 1, 2003
Submitter/Contact Person:
Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343
Phone: (952) 930-6000 Fax: (952) 930-6496
Device Name and Classification:
Trade Name: AMS Apogee™ Vault Suspension System Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, polymeric Product Code: OTP Classification: Class II
Manufacturing Location:
American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343
Predicate Devices:
AMS Sparc Sling System - K011251, K013355, K020663 AMS Monarc Sling System - K023516 AMS BioArc - K030123 AMS Large Pore Polypropylene Mesh - K033636 IVS Tunneller - K010035
Indications for Use:
The Apoqee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ prolapse.
Device Description:
The Apogee™ Vault Suspension System consists of needles and connectors used to pass a polypropylene mesh for support of the vaginal vault.
Summary of Testing
The mesh used in the Apogee™ Vault Suspension System has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated
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K040537 page 2/2
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substantial equivalence to the predicate devices in terms of mechanical performance and biocompatibility.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is simple and recognizable, and it is often used on official documents and websites.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K040537 Trade/Device Name: Apogee™ Vault Suspension System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: March 1, 2004 Received: March 2, 2004
Dear Ms. Linke:
This letter corrects our substantially equivalent letter of April 22, 2004.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin R. Fuchs
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K040537
Device Name: Apogee™ Vault Suspension System
Indications For Use: The Apogee™ Vault Suspension System is intended for use in vaginal vault suspension to treat pelvic organ prolapse.
Prescription Use______________________________________________________________________________________________________________________________________________________________ × (Per 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_________________________________________________________________________________________________________________________________________________________________